The Reproducibility and Consistency of Instrument-assisted Soft Tissue Manipulation

Massage Clinical Trial

Official title:

The Reproducibility and Consistency of Instrument-assisted Soft Tissue Manipulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04923633
• Other study ID #: 10329
• Secondary ID: R41AT011494
• Status: Completed
• Start date: May 11, 2021
• Est. completion date: October 19, 2022

Study information

• Verified date: November 2023
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The overall purpose of this study is to objectively describe and test the consistency and reproducibility of instrument-assisted soft tissue manipulation (IASTM).The specific aims of this current study are to:

1. Analyze IASTM stroke patterns using objective metrics;

2. Test the consistency of force application, with and without visual monitoring of objective metrics, and;

3. Determine the reliability of dynamic pressure pain threshold assessment. The ultimate goal of this continuing line of research is to improve soft tissue manual therapy practice in research, education, and clinic for use as a non-invasive modality in soft tissue assessment and treatment. Results from this protocol will inform future clinical trials, including studies exploring the effects of different IASTM dose-loads in various musculoskeletal pain conditions.

Description:

This is a single-site study consisting of three study phases. Phase I will observe and analyze clinician's application of instrument-assisted soft tissue manipulation (IASTM) as a means to identify signature profiles for the stroke rate, angle, and direction that are characteristic of basic (e.g., linear, curved) stroke patterns. Phase II will assess the consistency of IASTM force application. Phase III will assess the reliability of dynamic pressure pain threshold assessment. Clinician participants (Phase I) will attend one study visit consisting of basic linear and curved IASTM stroke pattern applications and complete a questionnaire. Total study duration for clinician participants will be 90 minutes. Non-clinician subjects will attend two study visits (Phase II) or one study visit (Phase III). Visits will consist of completion of questionnaires, application of IASTM strokes by a clinician using the QSTM device, and stretching.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: October 19, 2022
• Est. primary completion date: October 19, 2022
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

Phase I

1. Male or female between the ages of 18-75 years old.

2. Be a licensed, practicing healthcare clinician (e.g. physical therapist, massage therapist, osteopathic physician, athletic trainer, chiropractor)

3. Have at least 8 years of clinical experience in instrument-assisted soft tissue manual therapy

Phase II

1. Male and female subjects between 18-75 years old

2. Body Mass Index (BMI) = 18.5 kg/m2 but <30 kg/m2

Phase III

1. Male and female subjects, ages younger (=18 but =30yo) and older (=50 but =75yo)

2. Body Mass Index (BMI) = 18.5 kg/m2 but <30 kg/m2

Exclusion Criteria:

Phase I

1. <8 years of clinical experience in instrument-assisted soft tissue manual therapy practice

2. Any known pain conditions, such as nerve impingement (radiculopathies), rheumatoid arthritis, osteoarthritis, or any other inflammatory conditions that could interfere with the participant's ability to perform basic IASTM stroke patterns.

3. Any known cardiovascular, pulmonary, or metabolic disease that could interfere with the clinician's ability to perform basic IASTM stroke patterns.

Phase II

1. Known cardiovascular, pulmonary, or metabolic disease;

2. Current smoking or those who quit smoking within the previous 6 months;

3. Current use of anti-inflammatory or analgesics;

4. Any history of back, neck, lower extremity, or abdominal surgery or injury; or back, neck, or leg pain within the previous 6 months that impaired function;

5. Any co-morbidities that could contribute to back, neck, or leg pain (e.g., radiculopathies, rheumatoid arthritis, osteoarthritis, inflammatory conditions).

Phase III 1. The same exclusion criteria as for Phase II.

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Related Conditions & MeSH terms

• Massage

Intervention

Device:
• Quantifiable Soft Tissue Manipulation (QSTM)
Quantifiable soft tissue manipulation (QSTM) is a force sensing device system that can be used by a clinician to apply a massaging force while the system monitors objective metrics, i.e., the amount, rate, and angle of force applied.

Locations

Country	Name	City	State
United States	Indiana University	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase I Stroke Pattern Characteristic Descriptions	The objectives metrics from quantifiable soft tissue manipulation device system will be analyzed for common or characteristic applications between clinicians.	Analysis results within 6 months.
Primary	Phase II Reliability of IASTM Force Application	The agreement in soft tissue manipulation force application, between and within clinicians, will be determined within a single session and between session (within 7 days apart).	Measured within 2 hours for same day reliability and at 7 days for between day reliability. Results reported by end of study at one year
Primary	Phase III Reliability of Dynamic Pressure Pain Threshold Assessment	The agreement between and within clinicians in pressure pain threshold assessment over a body area will be determined within a single session.	Measured within 2 hours on same day of testing. Results reported by end of study at one year.
Secondary	(Phase III Only) Heart Rate	Radial pulse will be palpated to determine heart rate (in beats per minute, BPM).	Measured before and within 2 hours after IASTM force application. Results reported by end of study at one year.
Secondary	(Phase III Only) Blood Pressure	Will determine systolic and diastolic blood pressure (in mmHg) using a stethoscope and sphygmomanometer.	Measured before and within 2 hours after IASTM force application. Results reported by end of study at one year.
Secondary	(Phase III Only) Range of Motion	Will measure the amount (range) of trunk movement (in degrees) using a modified protractor.	Measured before and within 2 hours after IASTM force application. Results reported by end of study at one year.
Secondary	(Phase III Only) Hamstring Length Flexibility Test.	Will measure the amount (range) of passive knee extension movement available (in degrees) with the hip stabilized at 90 degrees using a modified protractor.	Measured before and within 2 hours after IASTM force application. Results reported by end of study at one year.
Secondary	(Phase III Only) Trunk Forward Bend Flexibility Test.	A tape measurer/ruler will be used to determine the extensibility (e.g. limberness) of the posterior (back) trunk soft tissues during seated trunk forward bend (reaching) muscle length test (change from start to end of test measured in centimeters).	Measured before and within 2 hours after IASTM force application. Results reported by end of study at one year.
Secondary	(Phase III Only) Strength	A handheld dynamometer will be used to test the strength (Newtons of force) of the subject's back and thigh.	Measured before and within 2 hours after IASTM force application. Results reported by end of study at one year.
Secondary	(Phase III Only) Static Pressure Pain Threshold	This test will determine a subject's pressure pain sensitivity in a single spot using a non-invasive device, i.e. static algometer.	Measured before and within 2 hours after IASTM force application. Results reported by end of study at one year.
Secondary	(Phase III Only) Skin Surface Temperature	Changes in skin surface temperature will be determined using an infrared thermometer of the skin are where IASTM is applied on the back and thigh.	Measured before and within 2 hours after IASTM force application. Results reported by end of study at one year.
Secondary	(Phase III Only) 10-Meter Walk Test (10-MWT)	Maximal walking speed (MWS) (in meters/sec) will be determined using the 10-meter walk test as a functional performance measure.	Measured before and within 2 hours after IASTM force application. Results reported by end of study at one year.
Secondary	(Phase III Only) Vertical Jump Test	The vertical jumping height (in centimeters) (only in subjects 18-30 y.o.) will be determined as a functional performance measure	Measured before and within 2 hours after IASTM force application. Results reported by end of study at one year.